Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System

Not Applicable

Completed

Conditions: May-Thurner Syndrome
Deep Vein Thrombosis
Chronic Venous Insufficiency

Interventions: Device: Duo Venous Stent System

Registration Number: NCT04580160

Lead Sponsor: Vesper Medical, Inc.

Brief Summary: This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to investigate the safety and efficacy of the Vesper DUO Venous Stent System as compared to a pre-defined performance goal (PG) established from published, peer reviewed scientific literature related to stenting of iliofemoral venous outflow obstructions.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 162

Inclusion Criteria

Males or non-pregnant, non-breastfeeding females ≥18 years of age at the time of consent
Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to treatment and must use some form of contraception (abstinence is acceptable) throughout the time of clinical trial exit
Willing and capable of complying with all required follow-up visits
Estimated life expectancy ≥1 year
Subject is ambulatory (use of assistive walking device such as a cane or walker is acceptable)
Body mass index (BMI) <40
Clinically significant symptomatic venous outflow obstruction in one iliofemoral venous segment (one limb) per subject, is indicated for venoplasty and stenting, and meets at least one of the following clinical indicators:
1. Clinical-Etiology-Anatomy-Pathophysiology (CEAP) score ≥3
2. Venous Clinical Severity Score (VCSS) pain score ≥2
3. Suspected deep vein thrombosis (DVT) with symptoms occurring prior to receiving a DUO Stent
Subject is willing and able to comply with PI recommendation for compression therapy, if required
Presence of unilateral, non-malignant venous obstruction of the common femoral vein (CFV), external iliac vein (EIV), common iliac vein (CIV), or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter and confirmed by venographic or IVUS imaging. The cranial point of the obstruction may extend to the iliac vein confluence of the inferior vena cava (IVC) and the caudal point may be 2mm above either the inflow of the deep femoral (or profunda) or the lesser trochanter, whichever is most cranial
Obstructive lesion(s) able to be treated with continuous stent coverage
Adequate inflow to the target lesion(s) involving at least a patent femoral or deep femoral vein and a landing zone in the CFV free from significant disease requiring treatment
Reference vessel diameter is of adequate size to accommodate the appropriate size stent as measured by IVUS
All vessels from insertion site through target vessel can accommodate a 9F or 10F sheath, depending on the stent size used
Ability to cross interventional devices through target lesion(s)
In DVT subjects, successful treatment of acute thrombus must have occurred prior to receiving any DUO Stents for an underlying obstructive lesion. Successful treatment of acute thrombus is defined as reestablishment of antegrade flow with ≤30% residual thrombus (confirmed by venogram or IVUS) and freedom from bleeding and symptomatic pulmonary embolism (confirmed by imaging). After successful treatment of thrombus is confirmed, eligible obstructive lesion(s) can be treated with a DUO Stent during the same procedure.
All subjects must undergo a SARS-CoV-2 test and have a negative test result within 8 days of the index procedure. If a SARS-CoV-2 test is unavailable due to institution policy, a test shortage, or if there is a delay in test results, the subject must complete the COVID-19 questionnaire and must have answered NO to all questions to be eligible for enrollment. A SARS-CoV-2 test will not be required for enrollment if a subject has received a complete cycle of an authorized COVID-19 vaccine or has documented evidence of a positive COVID-19 antibody test and is asymptomatic and has no long-lasting effects (per PI discretion) from a prior COVID-19 infection.
A measured temperature less than 99.5°F (37.5°C) on the day of the index procedure and no history of fever or feeling feverish within 14 days of the index procedure
No prior history, within 60 days of the index procedure, of a SARS-CoV-2 positive test, or COVID-19 symptoms

Exclusion Criteria

Target limb symptoms caused by peripheral arterial disease
Presence of unresolved significant pulmonary embolism prior to use of the DUO Venous Stent System confirmed by chest CT. If subject has documented history of significant pulmonary embolism within the last 6 months, a chest CT is required to confirm significant pulmonary embolism is not currently present.
Presence of IVC obstruction or target venous obstruction that extends into the IVC
Presence of acute DVT located outside target limb
Contralateral venous occlusive disease of the CFV, EIV, and/or CIV, with planned treatment ≤390 days after the index procedure
Uncontrolled or active coagulopathy or known, uncorrectable bleeding diathesis
Coagulopathy causing INR >2 which is not amenable to medical treatment
Platelet count <50,000 cells/mm3 or >1,000,000 cells/mm3 and/or White blood cell (WBC) <3,000 cells/mm3 or >12,500 cells/mm3
Uncorrected hemoglobin of ≤9 g/dL
Subject is on dialysis or has an estimated glomerular filtration rate (eGFR) <30 mL/min. In subjects with diabetes mellitus, eGFR <45 mL/min.
History of Heparin Induced Thrombocytopenia
Presence of known aggressive clotting disorders such as Lupus Anticoagulant Disorder, Antiphospholipid antibody syndrome, homozygous gene Factor V Leiden or Prothrombin gene abnormalities, Protein C and S deficiency or Antithrombin deficiency
Known hypersensitivity or contraindication to antiplatelet therapy or anticoagulation, nickel, or titanium
Contrast agent allergy that cannot be managed adequately with pre-medication
Intended concurrent adjuvant procedure (except for venoplasty) such as creation of temporary arteriovenous fistula, femoral endovenectomy or saphenous vein ablation and/or saphenous vein stripping during the index procedure
Subjects who have had any prior surgical or endovascular procedures to the target vessel. Note that subjects who have had successful catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 90 days prior to the index procedure may be included
Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in subjects at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure
Planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) 30 days prior to or 30 days after the index procedure
Previous venous stenting of the target limb, the IVC, or contralateral limb if stents extend into the IVC
Iliofemoral venous segment unsuitable for treatment with available sizes of DUO Stent implants
Lesions with intended treatment lengths extending into the IVC
No safe landing zone at or above the profunda femoral confluence
Participating in another investigational study in which the subject has not completed the primary endpoint(s)
Has other comorbidities that, in the opinion of the Investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duo Venous Stent System Implantation	Duo Venous Stent System	-

Primary Outcome Measures

Name	Time	Method
Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days	30 days	Freedom from major adverse events (MAEs) at 30 days post index procedure, as adjudicated by the Clinical Events Committee (CEC) or Core Laboratory, including: * Device or procedure-related death * Device or procedure-related bleed at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion of ≥2 units * Device or procedure-related venous injury occurring in the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention * Major amputation of the target limb * Clinically significant pulmonary embolism (PE), confirmed by CT angiography * Stent embolization outside of the target vessel * Presence of new thrombus within the stented segment requiring surgical or endovascular intervention
Efficacy - Number of Participants With Primary Patency of Stented Segment at 12 Months	12 months	Primary patency of stented segment at 12 months defined as freedom from: * Duplex Ultrasound (DUS) core laboratory adjudicated occlusion or stenosis \>50% within the stented segment. If DUS shows \>50% stenosis or occlusion, confirmation by diagnostic intravascular ultrasound (IVUS) is required. * CEC adjudicated clinically driven target lesion reintervention (CD-TLR) defined as endovascular or surgical procedure for new, recurrent, or worsening symptoms and core lab adjudicated \>50% stenosis or occlusion within the stented segment confirmed by diagnostic IVUS

Secondary Outcome Measures

Name	Time	Method
VCSS Pain Score and Changes in VCSS From Baseline in ITT Patients	12 months	The Venous Clinical Severity Score (VCSS) system is a scoring system used to categorize nine attributes of venous disease. For this study, only the Pain Score was collected. The levels of pain severity ranged from 0 (none) to 3 (severe).
Number of ITT Subjects With Primary Assisted Patency at 12 Months	12 months	Primary assisted patency is defined as freedom from DUS core laboratory adjudicated occlusion or stenosis \>50% within the stented segment following a reintervention due to a \>50% but \<100% stenosis. If DUS shows \>50% stenosis or occlusion, confirmation by diagnostic IVUS is required.
Number of ITT Subjects With Secondary Patency at 12 Months	12 months	Secondary patency at 12 months defined as freedom from DUS core laboratory adjudicated occlusion or stenosis \>50% within the stented segment following a reintervention due to 100% occlusion. If DUS shows \>50% stenosis or occlusion, confirmation by diagnostic IVUS is required.

Trial Locations

Locations (30): University Clinical Research-Deland LLC
🇺🇸
Winter Park, Florida, United States
Piedmont Atlanta Hospital
🇺🇸
Atlanta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Stony Brook Medicine
🇺🇸
Stony Brook, New York, United States
The Ohio Health Research Institute
🇺🇸
Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Houston Healthcare Medical Center
🇺🇸
Houston, Texas, United States
Midwest Cardiovascular Research Foundation
🇺🇸
Davenport, Iowa, United States
Cardiovascular Institute of the South
🇺🇸
Opelousas, Louisiana, United States
Hurricane Cardiology Research
🇺🇸
New Braunfels, Texas, United States
Lake Washington Vascular, PPLC
🇺🇸
Bellevue, Washington, United States
Mount Sinai Medical Center of Florida
🇺🇸
Miami, Florida, United States
MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Holy Name Medical Center
🇺🇸
Teaneck, New Jersey, United States
The Vascular Experts
🇺🇸
Darien, Connecticut, United States
Edgewood Hospital and Medical Center
🇺🇸
Englewood, New Jersey, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
The Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
University Hospital in Opole
🇵🇱
Opole, Poland
St. Joseph Hospital
🇺🇸
Orange, California, United States
Palm Vascular Centers
🇺🇸
Miami Beach, Florida, United States
Michigan Outpatient Vascular Institute
🇺🇸
Dearborn, Michigan, United States
Columbia University Irving Medical Center
🇺🇸
New York, New York, United States
Atrium Health
🇺🇸
Charlotte, North Carolina, United States
North Dallas Research Associates
🇺🇸
McKinney, Texas, United States
Sentara Clinical Research
🇺🇸
Norfolk, Virginia, United States
Medical College of Wisconsin, Vascular & Interventional Radiology, Froedtert Hospital Radiology, Rm 2803
🇺🇸
Milwaukee, Wisconsin, United States
Medical University of Karol Marcinkowski
🇵🇱
Poznań, Poland
Stanford University
🇺🇸
Palo Alto, California, United States